BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2003351 · Received March 1, 2011

    Report

    Report Number
    1628664-2011-00095
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RAN PRECISION DIAGNOSTIC CHECKS AND ALL PASSED. THE CUSTOMER RAN A PRECISION TEST USING THE TORCH POSITIVE QC TWICE IN REPLICATES OF 11. EACH TIME THE FIRST REP WAS LOW, BUT THE OTHER POINTS WERE IN RANGE AND PRECISE. IT WAS RECOMMENDED THAT THE CUSTOMER REPLACE THE ARCHITECT R1 AND R2 PROBES. THE CUSTOMER REPLACED AND RAN ANOTHER PRECISION TEST ON THE C-PEPTIDE ASSAY. THE CUSTOMER CHOSE TO RUN C-PEPTIDE AS THE TOXO IGG QC IS VERY EXPENSIVE. PRECISION WAS GOOD FOR C-PEPTIDE, AND THE ISSUE WAS RESOLVED. A SEARCH OF THE SERVICE HISTORY FOR THE ARCHITECT I2000SR INSTRUMENT WAS PERFORMED. THE SEARCH DID NOT IDENTIFY ANY INSTRUMENT ISSUES RELATED TO THIS COMPLAINT. A SEARCH FOR SIMILAR COMPLAINTS WAS PERFORMED. THE SEARCH DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RELATED TO THIS COMPLAINT. THE CURRENT RATES FOR ARCHITECT I2000 ERRATIC COMPLAINTS/MILLION TESTS AND OCCURRENCES/MILLION TESTS ARE BELOW THE INTERNAL RATES DOCUMENTED AT LAUNCH OF THE INSTRUMENT. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A POSITIVE ARCHITECT TOXO IGG RESULT OF 43 IU/ML WAS GENERATED ON A FEMALE PATIENT ON THE NIGHT OF (B)(6), 2011. THE FOLLOWING MORNING, THE SAME SAMPLE WAS RETESTED AND A NEGATIVE RESULT OF 0.1 IU/ML WAS GENERATED. THE CUSTOMER STATED THAT THE CORRECT RESULT IS NEGATIVE BASED ON PREVIOUS TESTING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT TOXO IGG LIST 6C19-25, LOT UNKNOWN| ARCHITECT TOXO IGG LIST 6C19-25, LOT UNKNOWN